Evaluation of the Effect of Aligner Seaters on the Predictability of Tooth Movement in Clear Aligner Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Primary outcome measure
研究概览
简要总结
The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan.
- Group A (Regular-use group): Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds.
- Group B (customized-use group): In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.
详细描述
A single-operator, multi-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted among patients seeking orthodontic treatment with clear aligner therapy. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Eligible participants will be randomly assigned to one of two aligner seater (chewy) use protocols. To minimize inter-operator variability, all participants will be treated by the same orthodontist.
A standardized clinical protocol will be followed. Each participant will undergo extraoral and intraoral photography, intraoral scanning using the Medit i700 scanner (Medit Corp., Seoul, South Korea), and radiographic assessment including cone-beam computed tomography (CBCT) and lateral cephalometric radiography.
On the day of aligner insertion, gingival index and plaque index will be recorded. The teeth will be isolated and cleaned with a water-pumice slurry using a rubber polishing cup mounted on a low-speed handpiece. The enamel surfaces will be rinsed and dried with oil-free compressed air, followed by conventional acid etching with 37% phosphoric acid for 30 seconds. The etched surfaces will then be rinsed for 10 seconds according to the manufacturer's instructions and air-dried until a frosty white appearance is observed.
A universal adhesive (BISCO All-BOND UNIVERSAL, USA) will be applied to the etched enamel surfaces using a nylon brush, followed by gentle air thinning for 2 seconds with the air stream directed perpendicular to the enamel surface. Attachment templates will be filled with Neo Spectra™ ST Universal Composite (Dentsply Sirona), a nanohybrid composite material, and attachments will be bonded according to the aligner manufacturer's prescribed attachment positions. The composite will then be light-cured for 20 seconds.
Group A (Regular-use group): Participants will use the aligner seater during the initial insertion of each new aligner for one to two days, or until the aligner is fully seated without visible gaps. Participants will be instructed to bite on the aligner seater for a few seconds while the aligner is in place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants.
- •Age between 18 and 45 years.
- •Mild to moderate crowding or spacing.
- •ANB angle between 1° and 5°.
- •Planned for non-extraction clear aligner treatment.
- •Willing and able to provide written informed consent and comply with the study protocol.
排除标准
- •Craniofacial syndromes (e.g., cleft lip and/or palate) or other congenital craniofacial anomalies.
- •Severe crowding.
- •Signs and/or symptoms of temporomandibular disorders (TMD).
- •Previous orthodontic treatment.
结局指标
主要结局
Primary outcome measure
时间窗: Four months
Tooth movement predictability will be assessed as the absolute difference between the prescribed and achieved tooth movement in linear (mm) and angular (degrees) measurements using three-dimensional digital model superimposition. Digital models will be analyzed using Geomagic Control X software.
次要结局
- Pain during clear aligner therapy(1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner.)
- Periodontal health(Baseline and every monthly follow-up visit throughout the 4-month study period)
研究者
Farah Alaa Hussein
master student of orthodontics
University of Baghdad